The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Non-contact Tonometer, Model Nt-4000.
| Device ID | K031733 |
| 510k Number | K031733 |
| Device Name: | NON-CONTACT TONOMETER, MODEL NT-4000 |
| Classification | Tonometer, Ac-powered |
| Applicant | NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-04 |
| Decision Date | 2003-12-04 |
| Summary: | summary |